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510(k) Data Aggregation

    K Number
    K203168
    Device Name
    LifeLens Wireless ECG Monitor
    Manufacturer
    LifeLens Technologies, Inc.
    Date Cleared
    2021-07-20

    (270 days)

    Product Code
    DSH
    Regulation Number
    870.2800
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K163535
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LifeLens Wireless ECG Monitor is indicated for use on patients who may be asymptomatic or who may suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain and/or anxiety. The LifeLens Wireless ECG Monitor is intended for use by patients 18 years or older. The LifeLens Wireless ECG Monitor is not intended to be worn during defibrillation.

    Device Description

    The LifeLens Wireless ECG Monitor is an ambulatory electrocardiograph (ECG) monitor system intended to continuously capture a single channel electrocardiogram from a subject. The Monitor consists of three components, a) disposable skin adhesive component (SAC) (also referred to as the Patch), b) reusable Hub, and c) reusable Gateway (or Gateway Recharger Case).

    The SAC is a single-use disposable, passive, hypoallergenic, thin, and breathable skin interface to which the Hub connects hermetically. It is placed vertically along the sternum of the subject during use.

    The Hub is a small, reusable, battery powered component including an electrical interface for coupling to the SAC, and hardware to record, store, and transmit the electrocardiogram from the subject during use. Additionally, the Hub includes microphones and tap detection circuitry to facilitate annotation (i.e., audio recordings) of symptoms by the user.

    The Gateway Recharging Case is a battery-powered device for storing and charging two Hubs, interfacing with the Hub(s) during use, storing complete patient data, and allowing users to the data after use. The Gateway receives information wirelessly over the BLE communication channel from the Hub. The Gateway manages device use and coordinates any notifications to the user about hub power status, gateway power status, etc.

    The system can interface wirelessly with a computer via Bluetooth LE to provide real-time data to assist in patient set-up by the Health Care Professional (HCP). The real-time data provides a means to confirm system function and signal quality. The system can also interface through the USB interface on the Gateway with a computer to offload ECG data for further archiving or analysis purposes. Only the ECG recording portion is part of this 510(k) application.

    AI/ML Overview

    The LifeLens Wireless ECG Monitor is indicated for use on patients 18 years or older who may be asymptomatic or suffer from transient symptoms such as palpitations, shortness of breath, dizziness, pre-syncope, syncope, fatigue, chest pain, and/or anxiety. It is not intended to be worn during defibrillation.

    The device was compared to a myPatch® sl (K163535) predicate device.

    Here's an overview of the acceptance criteria and study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the performance testing summary indicates that the LifeLens Wireless ECG Monitor's performance was evaluated against generally accepted standards and clinical equivalence, demonstrating substantial equivalence to a predicate device.

    Key Performance Assessments and Outcomes:

    Performance AreaAcceptance Criteria (Implied)Reported Device Performance
    ECG Signal QualitySubstantial equivalence to reference 12-lead ECG, analytically (Signal-Noise Ratio) and clinically (cardiologist assessment).Signals compared analytically via Signal-Noise Ratio comparisons and found to be substantially equivalent. Cardiologists assessed signals for signal quality, quantitative measurements, and rhythm interpretation and found significant correlation with no clinically relevant differences.
    Wear and Comfort (Long-term)Acceptable comfort, no limitations, no skin health issues, acceptable battery life, connectivity, and memory.All 18 subjects concluded the device was comfortable and wearable, with no issues of skin health or damage. Acquired signals were deemed acceptable by cardiologists. Battery life, connectivity, and available memory were acceptable.
    BiocompatibilityMeet standards for cytotoxicity, irritation, and skin sensitization.Passed cytotoxicity, irritation, and skin sensitization tests.
    Usability/Human FactorsSatisfy usability engineering principles and ensure safe and effective use.Human Factors and Usability Testing was performed. The results are not detailed but are implied to be acceptable as part of the overall conclusion.
    Electrical/Mechanical SafetyCompliance with relevant IEC 60601 series standards for basic safety and essential performance, including electromagnetic compatibility and home healthcare environments.Mechanical/Electrical Safety and Essential Performance Testing was conducted, and the device was found to be in compliance with applicable standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-47, IEC 62366-1, IEC 60601-1-11).
    Wireless Co-existenceSafe and effective operation in wireless environments.Wireless Co-Existence testing was performed. The results are not detailed but are implied to be acceptable as part of the overall substantial equivalence conclusion.

    2. Sample Size and Data Provenance (Test Set)

    • Co-Monitoring Comparative Study:
      • Sample Size: 15 subjects.
      • Data Provenance: Not explicitly stated, but clinical studies are generally prospective. The phrase "a study was conducted" implies prospective data collection. The country of origin is not specified.
    • Wear and Comfort Study:
      • Sample Size: 18 subjects.
      • Data Provenance: Not explicitly stated, but implies prospective data collection. The country of origin is not specified.

    3. Number of Experts and Qualifications for Ground Truth (Test Set)

    • Co-Monitoring Comparative Study:
      • Number of Experts: "Cardiologists" (plural), specific number not provided.
      • Qualifications: "Cardiologists" are medical doctors specialized in heart conditions. No specific years of experience or board certifications are mentioned.
    • Wear and Comfort Study:
      • Number of Experts: "Cardiologists" (plural), specific number not provided.
      • Qualifications: "Cardiologists" are medical doctors specialized in heart conditions. No specific years of experience or board certifications are mentioned.

    4. Adjudication Method (Test Set)

    The document does not specify a formal adjudication method (e.g., 2+1, 3+1). It states that "Cardiologists assessed the signals," implying a consensus or independent review process, but the specific mechanism is not detailed.

    5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

    No Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was mentioned. The studies focused on the performance of the device itself and its equivalence to a reference device, as well as wearability. The device is an ECG monitor, not explicitly an AI-driven interpretation system.

    6. Standalone Performance Study

    Yes, standalone performance was implicitly done. The "Co-Monitoring Comparative study" and "Wear and Comfort study" evaluated the LifeLens Wireless ECG Monitor's performance (signal quality, wearability, battery life, connectivity, memory) on its own, comparing its output to a reference ECG device and assessing subjects' experience with the device itself. The "ECG recording portion" is what is being cleared, indicating an evaluation of the algorithm's ability to capture and record signals.

    7. Type of Ground Truth Used (Test Set)

    • Co-Monitoring Comparative Study:
      • Ground Truth for Signal Quality/Interpretation: Reference 12-lead ECG recordings from a separate device, and assessment by "cardiologists" for signal quality, quantitative measurements, and rhythm interpretation. This can be considered a form of "expert consensus" against a gold standard (12-lead ECG).
    • Wear and Comfort Study:
      • Ground Truth for Comfort/Wearability: Subject feedback (questionnaires) and observations for skin health, along with cardiologists assessing the acquired signals for acceptability.

    8. Sample Size for the Training Set

    The document does not provide information on a training set sample size. This suggests that the device's core function (ECG capture) did not involve a machine learning model that required a distinct training phase in the context of this 510(k) submission. If there were internal software algorithms, their validation was likely covered under "Software verification and validation."

    9. How the Ground Truth for the Training Set Was Established

    As no training set is mentioned for an AI/ML model, the establishment of ground truth for a training set is not applicable or described in this document. The focus is on the performance of the ECG monitoring hardware and its signal acquisition capabilities.

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